A Study of CAR-T Cells Targeting B Cell Related Autoimmune Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Beijing Boren Hospital
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Dose Limiting Toxicity
Study Overview
Brief Summary
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in patients with autoimmune disease.
Detailed Description
Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs.
Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors.
CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in autoimmune disease.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, between 18 and 56 years old;
- •Diagnosed with Autoimmune Diseases；
- •Good organ functions;
- •Voluntary participates this trial and can comprehend and sign ICF.
Exclusion Criteria
- •Had or has active malignancy;
- •Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
- •Combined with other autoimmune disease that needs treatment;
- •Pregnant or lactating women;
- •Has other factors that deemed not suitable by investigator.
Arms & Interventions
CAR-T treatment
Intervention: CAR-T (Drug)
Outcomes
Primary Outcomes
Dose Limiting Toxicity
Time Frame: 0~28 day after treatment
Frequency of AEs, SAEs
Time Frame: 0 day to 24 months after treatment
Secondary Outcomes
No secondary outcomes reported